Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Cortisol |
Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase body's metabolism of glucose control blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by body to ensure the balance is correct. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Perceived Stress Scale (PSS) |
The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Job Stress Scale |
The job stress scale from Ministry of Labor is a rating tool used to gauge of stress. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Overwork Survey |
This survey is used as self-evaluation of whether an employee overworks, based on the Overwork Survey by Occupational Safety and Health Administration, Ministry of Labor. The survey includes personal-related overwork and work-related overwork. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Insomnia Severity index (ISI) |
The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome.The minimum total score possible is 0 and the maximum total score possible is 28. Higher values represent a worse outcome. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
The State Trait Anxiety Inventory (STAI) |
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Depression Anxiety Stress Scales (DASS-42) |
The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 |
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life. The minimum total score possible is 14 and the maximum total score possible is 70. The higher score the better satisfaction. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
VAS-GI |
Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Patient Global Impression scales of Improvement rated by patient, PGI-C |
The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Serotonin |
Levels of serotonin in serum |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
GABA |
Levels of GABA in serum |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Norepinephrine |
Levels of Norepinephrine in serum |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Immunoglobulin A, IgA |
Levels of Immunoglobulin A, IgA in serum |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
adrenocorticotropic hormone, ACTH |
Levels of adrenocorticotropic hormone, ACTH in serum |
From Baseline to 8 Weeks Assessed |
|
| Secondary |
Total Antioxidant Capacity , TAC |
Levels of Total Antioxidant Capacity , TAC in serum |
From Baseline to 8 Weeks Assessed |
|
